Novavax, the small, Maryland-based company that has been struggling for months to bring its promising protein-based COVID-19 vaccine to market, announced a setback yesterday in its quest for an emergency use authorization (EUA) in the United States, sending its share prices tumbling today. The U.S. government has ordered Novavax to stop making vaccine in the United States and said it will offer the company no more funding until it passes muster with the Food and Drug Administration’s (FDA’s) strict manufacturing requirements, such as ensuring each lot of vaccine has the same potency.
“The U.S. government has recently instructed [us] to prioritize alignment” with FDA’s methods for ensuring consistency in manufacturing, the company wrote in a quarterly report filed yesterday. The government “further indicated that [it] will not fund additional US manufacturing” until the firm has done so.
Meeting FDA’s testing requirements “is just taking time. This interaction with [the U.S. government] is part of the normal course of business,” company spokesperson Amy Speak wrote in an email to ScienceInsider today. “We are continuing to work with the FDA and the US Government to finalize our filing package for EUA as rapidly as possible.”
Novavax’s large North American trial in June produced efficacy results on par with messenger RNA vaccines, with 90% efficacy against symptomatic COVID-19 and 100% efficacy against moderate and severe disease. The company has struggled with manufacturing issues, but in June said it planned to file with FDA for an EUA in the third quarter. Yesterday, it pushed that plan to the fourth quarter. The New York Times reported anonymous Biden administration sources saying that it’s not clear whether or when the vaccine will be authorized in the United States, which has funded the company with $1.75 billion to develop and make its vaccine.
Despite its setback in the United States, where contractors make the vaccine in North Carolina and Texas, Novavax is pushing ahead with manufacturing in other countries. The company also announced yesterday that, with its partner the Serum Institute of India, it has filed for EUAs in India, the Philippines, and Indonesia—its first such filings. It also expects this month to file an application for emergency use with the World Health Organization, which is a prerequisite for exports to many countries.
“US manufacturing is separate from the manufacturing network that is making the doses destined for [the rest of the world]. There should be no impact on that supply,” Speak wrote.
Novavax has agreed to supply more than 1 billion doses of its vaccine to countries around the world, including 350 million doses to be provided to poorer countries through the COVID-19 Vaccines Global Access Facility. The company also finalized on 4 August an advance purchase agreement with the European Union for up to 200 million doses. It says it will complete its emergency authorization application there and in the United Kingdom in the third quarter.
Novavax’s stock fell 20% today, to $190. But some stock analysts shrugged off the U.S. manufacturing news, saying a myopic focus on the United States overlooks the vaccine’s quality and the intense desire and market for it globally.
“We believe the company has the [needed] analytic assays in hand as it has initiated the submission process to various regulators that should have similar requirements [to FDA],” analyst Charles Duncan of Cantor Fitzgerald wrote in a note to investors today.
Mayank Mamtani of B. Riley Securities says the U.S. news “doesn’t matter given the urgent need for the Novavax vaccine in markets where they have a clear regulatory path.”
Mamtani expects the Novavax shot will play an important role in the United States as a booster for currently authorized vaccines. The company released results yesterday of a clinical study of a booster dose of its vaccine, given to participants from its large North American trial about 6 months after their second dose. The third jab quadrupled participants’ levels of neutralizing antibodies.